Implantable sling for the treatment of incontinence and method of using the same

ABSTRACT

An implantable sling for the treatment of male or female incontinence and method of implementing the same. The sling comprises a urethral support portion and at least one anchoring portion extending therefrom. The anchoring portion is operatively positioned through the obturator foramen and about at least one ramus portion of the pelvis such that the support portion of the implant is operatively positioned at or distal to the bulbar urethra (male) or mid-urethral region (female) to treat urinary incontinence. In a preferred embodiment, the implant will have first and second anchoring portions extending from the support portion with each respective one of said anchoring portions being operative to be secured about dedicated ones of the patient&#39;s pubic ramus. The implants may further be fabricated from tissues, synthetic materials or combinations thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims benefit of U.S. Provisional ApplicationSer. No. 60/773,565 filed Feb. 14, 2006, which is hereby incorporated byreference.

BACKGROUND OF THE INVENTION

The present invention is directed to surgical implants for the treatmentof male or female incontinence, and in particular, implantable slingsthat are operative to provide sling-type support at or distal to thebulbar urethral region (male) or mid-urethral region (female) of apatient and operatively anchored into position via fixation about thepatient's descending rami.

Of the estimated 19 million North American adults who have urinaryincontinence, 20% are estimated to be men. Such condition can range inseverity from partial to complete loss of bladder control and patientsafflicted with urinary incontinence can experience varying degrees ofurine loss. In addition, it is known that urinary incontinence maychange over time and that men and women with light incontinence, forexample, may experience minimal leakage during the occurrence of aprovocative event, such as laughing or coughing, whereas men and womenwith heavy incontinence may experience continuous urine leakage.

Generally, urinary incontinence is not considered a disease, but rathera symptom or side effect of another medical condition. Some conditionsknown to cause male urinary incontinence include prostate surgery, andin particular total prostatectomy, head and spinal cord injury,infection, certain toxins, such as too much alcohol consumption, certainmedications, such as sedating medications, and certain diseases, such ascancer, Parkinson's disease and multiple sclerosis. Indeed, maleincontinence can be caused simply by virtue of the aging process oremotional distress. Female incontinence may be caused by weakened and(or) stretched pelvic muscles, which is associated with child-birth,pregnancy, trauma, prior surgical procedures, and estrogen loss.

Each case of incontinence, however, is unique and no two people areaffected by incontinence in the same way. There are, however,well-recognized types of incontinence and various ways to treat thesame. Stress incontinence, which is a common type of incontinence, maybe characterized as urine leakage during a provocative event such assneezing, laughing, lifting heavy objects, or when the patient engagesin any type of exercise that puts pressure on the bladder. Urgeincontinence occurs when the patient wants to urinate but is incapableof exercising restraint until reaching a restroom. Additional types ofincontinence include. overflow incontinence, which occurs when thequantity of urine exceeds the capacity of the patient's bladder, andfunctional incontinence, which occurs when the patient has knowledge ofthe need to urinate but simply cannot access a restroom quickly enoughdue to a physical obstruction or debilitation.

To treat urinary incontinence, several options are available. Among themore effective types of recognized treatment include behavioraltechniques, such as biofeedback, bladder training, and pelvic muscleexercises, and modifications of the patient's diet and fluid intake.With respect to the latter, it is known that eliminating or cutting backon certain types of substances, such as caffeine and alcohol, can helpalleviate incontinence. There are additionally medications available,such as dicyclomine (Bentyl), flavoxate (Urispas), hyoscyamine sulfate(Anaspaz), imipramine (Tofranil), oxybutynin (Ditropan), tolterodine(Detrol), and propantheline (Pro-Banthine), phenylpropanolamine(Dexatrim), and pseudoephedrine (Sudafed) that are helpful incontrolling urinary incontinence.

Surgery may additionally be an option to treat male and female urinaryincontinence. Along these lines, surgical implants for males, such asthe In-Vance device, produced by American Medical Systems, Inc., ofMinneapolis, Minn., is a commercially available surgical implant thatmay be operative to provide structural support to the urethra for thetreatment of stress incontinence. In this regard, the implant isoperative to provide structural support to the urethra such that duringa provocative event, the device will provide structural support to theurethra thus causing the urine to be retained within the bladder and notleak through the urethra. Likewise, surgical implants for females, suchas the In-Fast Ultra device, produced by American Medical Systems, Inc.,of Minneapolis, Minn. is a commercially available surgical implant thatmay be operative to provide structural support to the urethra for thetreatment of stress incontinence.

Utilizing sling implants to treat incontinence, however, has been knownto have numerous drawbacks. Securing suburethral sling implants intoposition typically requires the use of bone screws, which are well-knownin the art to be difficult and time consuming to deploy, and can resultin significant patient discomfort, especially within the first couple ofweeks following the surgical implantation.

In addition, implanting suburethral slings are often times difficult tosecure into position with the optimal degree of tension. Indeed, theimplantation of suburethral slings for the treatment of incontinence iswell-recognized as complex, time consuming and can produce suboptimalclinical outcomes. Moreover, it is well recognized among surgeons thatperform such implant procedures that sutures attached to bone anchorsand/or sutures attached to bone screws utilized to secure the sling intoposition frequently break and that often times additional bone anchorsor screws must be secured into position. In fact, each suture attachedto bone anchors and or bone screws must typically be retensioned two tothree times before optimal sling positioning and structural support tothe urethra is achieved.

Accordingly, there is a substantial need in the art for a suburethralsling implant for the treatment of incontinence that is substantiallyeasier to surgically secure into position and that can further providean optimal degree of urethral support to thus effectively treat urinaryincontinence. There is additionally a need in the art for an implantthat is of simple construction, easy to surgically manipulate, and canbe manufactured at relative low cost utilizing known implant materials,whether it be synthetic materials, natural tissues, or combinationsthereof. There is yet a further need in the art for such an implant thatcan be secured into position such that the implant defines a suburethralsling portion operatively positioned at or distal to the bulbar urethraof the patient (male) or mid-urethral region (female) that remainsanchored into position via the use of an anchoring portion that extendsthrough the obturator foramen and remain secured at or near thedescending rami of the patient's pelvis without the use of bone anchors.With respect to the latter, it would be exceptionally advantageous forsuch a surgical implant that could be anchored to the pubis through theobturator foramen preferably via the descending rami thereof.

BRIEF SUMMARY

The present invention specifically addresses and alleviates theabove-identified deficiencies in the art. In this regard, the presentinvention is directed to suburethral sling implants and methods ofdeploying the same that are effective and substantially easier to deploythan prior art implants and implantation techniques for treatingincontinence. The implant comprises the combination of a urethralsupport portion and at least one anchoring portion. The support portionis operatively positioned at or distal to the bulbar urethra (male) ormid-urethral region (female). Per conventional suburethral slings, thesupport portion is operative to provide structural support to theurethra such that during the occurrence of a provocative event, thesling is operative to compressively engage the urethra to prevent urineleaking therefrom. The support portion will have a surface area that isat least 2 cm long by 1 cm wide to 8 cm long by 8 cm wide. Along theselines, it should be understood that the specific dimensions providedherein can vary by 50% or substantially greater, and retain its abilityfor use as an implant.

The anchor portion extends from the support portion. The anchor portion,which may take a variety of configurations, is operative to extendthrough the obturator foramen of the patient and become secured at alocus preferably at or near the descending ramus. To effectuate suchattachment, it is contemplated that one or more sutures or othersuitable means for attachment may be utilized to ensure that the anchorportion becomes secured about the ramus and that the support portionremains operatively positioned at or distal to the bulbar urethra (male)or mid-urethral region (female). In a preferred embodiment, the implantwill have at least two anchor portions extending from the supportportion with each respective anchor portion extending through theobturator foramen and attachable about respective ones of the patient'srami. The anchor portions will have a width ranging from between 0.5-4cm and the length ranging from at least 5.0 cm to 45.0 cm. Along theselines, it should be understood that the specific dimensions providedherein can vary by 50% or substantially greater, and retain its abilityfor use as an implant. To the extent necessary, both the support andanchor portions of the implant may be surgically fashioned as necessaryto optimize sizing and configuration of the implant to suit the needs ofa specific patient.

In certain embodiments of the implant of the present invention, the samemay take the form of implants having a central support structure withanchoring portions extending therefrom in opposed directions or may befashioned to have generally “H”, inverted “U”, or “X” shapes. Theimplants may further be provided as generally rectangular, square ortrapezoidal shapes and may further be provided with one or moreapertures to accommodate the attachment of sutures, surgical tacks andthe like. The implants of the present invention may further befabricated such that sutures are pre-attached thereto, per the teachingsof Applicants' co-owned pending U.S. patent application Ser. No.10/947,182, entitled READILY IMPLANTABLE SLING, filed Sep. 22, 2004, theteachings of which are expressly incorporated by reference. The implantsof the present invention may further be fabricated from any of a varietyof surgically compatible materials well-known in the art, includingsynthetic materials, such as synthetic mesh and the like, as well asnatural materials, such as harvested tissues from sources such asanimals, cadavers or the patient himself. The implants may further befabricated such that the same are formed from combinations of materials,including but not limited to combinations of different types ofsynthetic materials, combinations of different types of natural tissuesand/or combinations of both synthetic and natural tissues.

Regardless of the embodiment, in all procedures involving theimplantation of the implants of the present invention, such proceduresare performed with the patient assuming a lithotomy position. A verticalperineal (male) or vaginal (female) incision is made in the midlinedissecting to expose the bulbar urethra (male) or urethra (female) andthe inferior aspect of the descending rami bilaterally. A surgicalintroducer is utilized to introduce the implant into position, typicallythrough the obturator foramen, in a manner that is substantially easierand less traumatic than conventional surgical procedures utilized toaccess and implant slings for the treatment of male or femaleincontinence. Once the surgical site is accessed, the anchoring portionwill preferably be positioned through the obturator foramen and anchoredinto position. Surgical sutures and the like may be deployed tofacilitate anchoring of the anchor portions of the implant. Minorvariations well-known to those skilled in the art may necessarily bemade to effectuate optimal attachment and positioning of the supportportion of the implant, as may be necessary for a given patient. In allcases, however, the surgical procedures and implants of the presentinvention provide a radically more efficient, effective and lesstraumatic surgical approach to the treatment of male or femaleincontinence.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the various embodimentsdisclosed herein will be better understood with respect to the followingdescription and drawings, in which like numbers refer to like partsthroughout.

FIG. 1 is a frontal perspective view of a pelvis, a bladder and aurethra extending therefrom with a sling-type implant shown operativelysecured into position, the implant having a support portion aligned ator distal to the bulbar urethra and anchoring portions, the latter shownextending through the obturator foramen and secured about dedicated onesof the rami of each hip bone.

FIG. 2 is a side elevational view of the pelvis and implant of FIG. 1showing a respective one of the anchor portions of the implant securedabout the ramus.

FIG. 3 is a front elevational view of an implant for the treatment ofmale or female urinary incontinence as constructed in accordance withthe present invention.

FIG. 4 is a front elevational view of an implant for the treatment ofmale urinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 5 is a front elevational view of an implant for the treatment ofmale urinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 6 is a front elevational view of an implant for the treatment ofmale or female urinary incontinence as constructed in accordance withanother embodiment of the present invention.

FIG. 7 is a front elevational view of an implant for the treatment ofmale urinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 8 is a front elevational view of an implant for the treatment ofmale urinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 9 is a front elevational view of an implant for the treatment ofmale urinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 10 is a front elevational view of a pelvis, a bladder and a urethraextending therefrom with a sling-type implant shown operatively securedinto position, the implant having a support portion aligned at or distalto the bulbar urethra and anchoring portions, the latter shown extendingthrough the obturator foramen and secured about dedicated ones of therami of each hip bone.

FIG. 11 is a side elevational view of the pelvis and implant of FIG. 10showing a respective one of the anchor portions of the implant securedabout the ramus.

FIG. 12 is a partial front view of an implant for the treatment ofurinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 13 is a partial front view of an implant for the treatment ofurinary incontinence as constructed in accordance with anotherembodiment of the present invention.

FIG. 14 is a front elevational view of a photograph of examples ofintroducers for use with an implant as contemplated in accordance withthe present invention.

FIG. 15 is a front elevational view of a photograph of examples ofintroducers for use with an implant as contemplated in accordance withthe present invention.

FIG. 16 is a front elevational view of a photograph of an exemplaryintroducer for use with an implant as contemplated in accordance withthe present invention.

FIG. 17 is a front elevational view of a photograph of an exemplaryintroducer for use with an implant as contemplated in accordance withthe present invention.

FIG. 18 is a front elevational view of a photograph of an exemplaryintroducer for use with an implant as contemplated in accordance withthe present invention.

FIG. 19 is a front elevational view of a drawing of an exemplarytransvaginal or transperineal tool for use with an implant ascontemplated in accordance with the present invention.

DETAILED DESCRIPTION

Referring now to the drawings, initially to FIG. 1, there is shown animplant 10 for the treatment of male and female incontinence that isoperative to provide suburethral support to thus prevent the leakage ofurine, particularly when the patient experiences a provocative event. Inthis respect, the implant 10 is operative to act as a suburethral sling,as is known in the art, but is advantageously operative to be moreeasily secured into position than prior art sling implants. The implantsof the present invention are further capable of being deployed in amanner that is far less traumatic than prior art sling implants andmethods of surgically implanting the same, and further utilizing a novelattachment approach that provides for optimal suburethral positioning ofthe sling 10 in an exceptionally secure manner without the use of boneanchors.

In its broadest sense, the implants of the present invention comprisethe combination of a urethral support portion and at least one anchoringportion. The support portion is operatively positioned at or distal tothe bulbar urethra 28 (male) or mid-urethral region (female). Theanchoring portion is operative to secure the support portion intoposition to thus provide structural support to the urethra, andparticularly so during the occurrence of a provocative event. To achievethat end, the anchoring member is generally operative to extend throughthe obturator foramen and become secured at least one and preferablyboth of the patient's rami. In preferred embodiments of the invention,discussed more fully below, the anchor portion will be operativelyinterconnectable with the descending ramus of one of the patient'spelvis. Advantageously, the positioning of the anchor portion againstthe descending ramus will be accomplished without the use of bonescrews, which are well-known in the art to be problematic to deploy andutilized as an attachment point for sutures and the like.

The implants of the present invention further may take a variety ofembodiments. In certain of the embodiments depicted, the implant willinclude first and second attachment portions extending from the supportportion with each attachment portion being operatively extensiblethrough the obturator foramen and attachable to respective ones of thepatient's descending rami. Such attachment portions may be operative toextend in opposed directions from the support portion or, alternatively,extend in generally parallel relation to one another from the supportportion. In certain other embodiments, the support portion anchoringportion may be formed as a continuous segment or otherwise formed tohave a generally rectangular or trapezoidal shape. Moreover, in certainembodiments, the implants of the present invention may incorporate theuse of sutures or with other types of surgically implantable structuresand the like to facilitate attachment of the same into position.Specifically, it is contemplated that such embodiments may rely upon acombination of structures in combination with certain portions of theimplant to facilitate attachment and positioning thereof.

For purposes of defining the general parameters of implants of thepresent invention, it is presently believed that the support portion ofthe implant will define a surface area ranging from a 1 cm width by 2 cmlength to an 8 cm width by 8.0 cm length. With respect to the anchorportion, the same will preferably define a surface area defined by a 0.5cm width by 5.0 cm length to an area defined by a 4.0 cm width to a 45.0cm length. With respect to the latter, it should further be understoodthat certain embodiments of the present invention, discussed more fullybelow, sutures may be utilized in operative combination with theanchoring portion or, in certain embodiments, exclusively with thesupport portion, to thus define means for attaching and securing theimplant into position. In addition, it should be understood that thespecific dimensions provided herein for both the support and anchorportions can vary by 50% or substantially greater, and retain theirability for use as an implant.

With respect to the fabrication of the implants of the presentinvention, the same may be made from either synthetic materials, such assurgical mesh and the like, natural tissues, such as tissues harvestedfrom either an animal, cadaverous source or the patient himself, and/orcombinations of synthetic and natural materials. Along these lines, itis contemplated that the implants of the present invention can befabricated consistent with those methods disclosed in Applicant'sco-owned and co-pending U.S. patent application Ser. No. 10/684,861, theteachings of which are expressly incorporated herein by reference. Alongthese lines, it is further contemplated that in certain embodiments ofthe present invention, the implants may be prefabricated with slings orsutures attached thereto, consistent with the teachings of Applicants'co-owned pending U.S. patent application Ser. No. 10/947,182, entitledREADILY IMPLANTABLE SLING, the teachings of which are likewiseincorporated by reference.

Bearing the foregoing principles in mind, a detailed explanation isprovided herebelow with respect to the structure, properties andfunctioning of the implants of the present invention. Referring again toFIG. 1, the implant 10 is situated such that the support portion 12thereof is operatively positioned over the urethra. The implant 10 asdepicted includes first and second support portions 14, 16 that areshown extending through the obturator foramen 18 and wrapped aboutdedicated ones of the descending rami 20, 22 of hip bones 24, 26,respectively.

FIG. 2 more clearly depicts such engagement between a respective one ofthe anchor portions 14 as extending through the obturator foramen 18 andengaged with descending ramus 20 of hip bone 24. In this regard, theimplants 10 of the present invention generally operate on the principleof including attachment of the implant into position via an anchoringmechanism that extends through the obturator foramen and becomingsecured to at least one, and preferably both of the descending ramus ofthe patient; however, it should be understood that the descending ramuslocus is not to limit the scope of the present invention and thatattachment to any part of the periphery of the pubis and ischium may beconsidered suitable areas to which the implants of the present inventionmay be attached. Accordingly, fixation of the anchor portions at thedescending rami or any other structure should not be deemed limiting inany respect.

Bearing the foregoing principles in mind, and referring now to remainingFIGS. 3-9, there are shown various embodiments of the implants of thepresent invention. Referring to FIG. 3, implant 300 is defined bysupport portion 302 with anchor portions 304, 306 extending in opposeddirections therefrom. According to a preferred embodiment, the supportportion will have a width “A” of approximately 4 cm and a length “B” ofapproximately 6 cm. Anchor portions 304, 306 may extend from supportportion 302 via a tapered segment, as shown, and will have a length “C”of approximately 15 cm and a width “D” of approximately 2 cm. Asdiscussed above, the implant 300 may be fabricated from either syntheticand/or natural materials. It should be understood, however, that thespecific dimensions provided herein are not absolute, and variations inthe length and width of both the support portion 302 and anchor portions304, 306 can be readily made by those skilled in the art. Along theselines, it should be understood that the specific dimensions providedherein can vary by 50% or substantially greater, as discussed above, andretain its ability for use as an implant.

With respect to the procedure for implanting the implant 300 depicted inFIG. 3, Applicants believe that the best mode for performing the samewill require the patient to assume a lithotomy position. A verticalperineal incision will be made in the midline dissecting to expose thebulbar urethra in the inferior aspect of the descending ramibilaterally. A suitable introducer is then passed from inside out oroutside in through the upper aspect of the obturator foramen. A suturethat is attached to a respective one of the anchor portions 304 or 306is threaded through the introducer. The introducer is then retracted andthe suture is pulled until a respective one of the ends of the anchorportion 304 or 306 to which the suture is attached can be grasped. Thesupport portion 302 is then carried over the bulbar urethral complexand, thereafter, a second introducer is passed from inside out oroutside in on the contra-lateral side to thus enable the second otherrespective anchor portion extends through the obturator foramen. Thesecond introducer is then retracted and a suture affixed to therespective other anchor portion extends around the pubic ramus. Once sopositioned, tension is introduced to the implant 300 such that thesupport portion 302 thereof achieves optimal suburethral compression.The respective ends of anchor portions 304, 306 are then secured,preferably via attachment to support portion 302 at the edge of eachpubic ramus. To achieve that end, it is contemplated that a suture withor without an additional tensioning disc (not shown) is passed throughanchor portions 304, 306 to effectuate such attachment.

Referring now to FIG. 4, there is shown a further embodiment 400 for usein the surgical treatment of male urinary incontinence. As depicted, theimplant 400 includes a support portion 402 with first and second anchorportions 404, 406 depending therefrom in generally parallel relation toone another and additional anchor portions 404 a, 406 a, ascendingtherefrom to define an “H” shape. The implant 400, as depicted, ispreferably formed such that support portion 402 has a width “F” ofapproximately 7 cm and a height “G” of approximately 5 cm. Anchorportions 404, 406 preferably have a length “H” of approximately 30 cmand a width “I” of 1 cm. Additional anchor portions 404 a, 406 a willhave a width of approximately 1.5 cm and a height “J” of approximately14 cm, and may preferably be formed as extensions of 404 and 406,respectively. Again, such dimensions can be varied as may be deemedappropriate by one skilled in the art. Specifically, it should beunderstood that the specific dimensions provided herein can vary by 50%or substantially greater, and retain its ability for use as an implant.

In the embodiment depicted, anchor portions 404, 406 are operative toextend through the retropubic space, from posterior to symphysis, or mayextend via a transobturator route. Anchor portions 404 a, 406 a areoperative to pass through the rectus fascia from anterior to symphysis.

In accordance with the best mode discussed above with respect to implant300, the surgical procedure for implanting implant 400 will preferablybe conducted with the patient assuming a lithotomy position whereby avertical perineal incision will be made in the midline dissecting toexpose the bulbar urethra in the descending pubic rami bilaterally. Thebulbar spongiosis will be left intact. Thereafter, suprapubic transverseincisions of approximately 1 cm are made, 3 cm lateral to the midline oneither side. A suitable introducer is then passed from such incisionsand tunneled either superficially anterior to the pubic symphysis orretropubically and caused to exit through the initial perineal incision.A respective one of the ascending anchor portions 404 a or 406 a isattached to a suprapubic introducer 1700 and pulled through thesuprapubic incisions. This same maneuver is then repeated for therespective other ascending anchor portion 404 a or 406 a. Alternatively,the ascending anchor portions 404 a or 406 a may be “lifted up” throughthe perineal incisions by attaching them to a transperineal introducer1800 (FIG. 18) and tunneling the anchor portions either superficiallyanterior to the pubic symphysis or retropubically and causing them toexit along with the implant through the suprapubic incisions. Theprocedure using the transperineal introducer 1800 in this fashion alsocan be performed without first creating the suprapubic incisions. Inother words, the transperineal introducer 1800 can itself be used tocreate an exit opening in the abdominal area at the time the anchorportions are being moved suprapubically.

Hereafter, two new incisions, which are preferably approximately 1 cmabove the pubic symphysis are performed. The suitable introducer is thenpassed from above, retropubically, and out through the initial perinealincision. A respective one of the descending anchor portions 404 or 406is then attached to the introducer and pulled up through such newlyformed incision. Such procedure is repeated with respect to the otherdescending anchor portion 404 or 406, which as a consequence creates twosets of anchor portions, namely, descending anchor portions 404, 406 andascending portions 404 a, 406 a in the suprapubic region. The ascendinganchor portions 404 a, 406 a are then tunneled into the retropubicanchor portions 404, 406 beneath the skin and thereafter ascendingportion 404 a will be surgically connected with descending portion 404and ascending portion 406 a surgically attached to descending anchorportion 406. To achieve such surgical attachment, it is contemplatedthat such attachment may be attained via the use of sutures.

In a further refinement of such procedure, it is contemplated thatsurgical positioning of descending anchor portions 404, 406 can beaccomplished via the use of a suitable introducer that is passed fromoutside in or inside out through the obturator foramen. A suture that isattached to the distal most end of respective one of anchor portions404, 406 will be threaded to the introducer. Once the introducer isadvanced through the obturator foramen, the same is retracted with thesuture affixed to the end of descending anchor portion 404 or 406 ispulled until the end of the anchor portion 404 or 406 can be grasped. Asecond suitable introducer is utilized with respect to the surgicalpositioning of the respective other anchor portion 404 or 406 on thecontra-lateral side. Once so positioned, anchor portions 404 and 406 canbe affixed to ascending anchor portions 404 a, 406 a around thedescending rami via the transobturator approach and secured on itselfvia a suture line.

Referring now to FIG. 5, there is shown a further embodiment of animplant 500 falling within the scope of the present invention. Asdepicted, the implant includes a support portion 502 and first andsecond support portions 504, 506 depending therefrom in generallyparallel relation to define an inverted U-shape. The support portion 502further includes first and second apertures 508, 510 formed thereonthrough which dedicated sutures 512, 514 extend therethrough. Theimplant 500 is preferably fashioned such that the support portion 502has a length “K” of approximately 8 cm and a height “L” of approximately4 cm. Each respective anchor portion 504 will preferably have a length“M” of approximately 45 cm in length and a width “N” of approximately 1cm in length. Again, the dimensions of such implant can vary as will beunderstood by those skilled in the art. Specifically, it should beunderstood that the specific dimensions provided herein can vary by 50%or substantially greater, and retain its ability for use as an implant.

With respect to the implantation of the implant 500, the same is againperformed with the patient assuming lithotomy position. A verticalperineal incision is made in the midline dissecting to expose the bulbarurethra and the descending rami bilaterally leaving the bulbarspongiosis intact. One centimeter suprapubic transverse incisions aremade 3 cm laterally to the midline on either side. A suitable introduceris then passed from this “stab wound” and tunneled superficiallyanterior to the pubic symphysis (not retropubically) that exits throughthe initial perineal incision. A respective one of the sutures 512 or514 is attached to the introducer and pulled through the upper “stab”incision. This same procedure is repeated on the respective other sidewith respective other suture 512 or 514. Respective ones of the sutures512, 514 are tied down to the rectus fascia in the suprapubic area.

A suitable introducer is then passed from outside in or inside outthrough the obturator foramen. A suture that is attached to a respectiveone of the anchor portions 504 or 506 on one side is threaded throughsuch introducer. The introducer is retracted and the suture is pulleduntil the respective one of the ends of either 504, 506 (depending onwhich portion is attached) can be grasped. The same procedure isrepeated with respect to the other anchor portion 504 or 506 whereby asecond introducer is passed from outside in or inside out on thecontra-lateral side. Both free ends of anchor portions 504 or 506 willbe overlapped and secured. Along these lines, such anchor portions 504,506 will be tied around the descending rami via a transobturatorapproach and thus secured to itself via a suture.

In a variation of the embodiment and procedure discussed above withrespect to implant 500, it is contemplated that as opposed to the use ofapertures 508, 510 with dedicated suture lines 512 and 514 affixedthereto, the implant 500 may utilize thumb tack-like anchors (not shown)in the positions of 508 and 510, respectively. Such embodiment willfurther preferably include a support portion 502 that has a width “K” of7 cm as opposed to 8 cm. It should be understood that the specificdimensions provided herein can vary by 50% or substantially greater, andretain its ability for use as an implant.

To implant such embodiment, the patient will assume a lithotomy positionand a vertical perineal incision will be made in the midline dissectingto expose the bulbar urethra and descending rami bilaterally leaving thebulbar spongiosis intact. The support portion 502 will be attached viathese thumb tacks positioned where apertures 508 and 510 are depicted,respectively, on each side of the upper aspect of the descending ramiclose to the pubic symphysis.

A suitable introducer is then passed from outside in or inside outthrough the obturator foramen. A suture that is attached to a respectivedistal-most end of one of the anchor portions 504 or 506 is threadedthrough the introducer. The introducer is then retracted and the sutureis pulled until the distal-most end of a respective one of one of theanchor portions 504 or 506 can be grasped. This portion of a respectiveone of the anchor portions is wrapped around the ramus and tied down tothe support portion. A second introducer is passed from outside in orinside out on the contra-lateral side and the process is repeated withrespect to the respective other anchor portion 504 or 506. The supportportion 502 is then tacked down at the upper aspect of the descendingrami. The anchor portions 504, 506 are then tied around the descendingrami via the transobturator approach and then secured on itself viasuture attachment.

Referring now to FIG. 6, a further implant 600 is depicted. Asillustrated, the implant 600 comprises a generally rectangular implantdefining a middle support portion 602 with anchor portions 604, 606formed integral therewith and defining first and second opposed ends.According to such implant, the same will preferably be formed to have alength “O” of approximately 45 cm and a width “P” of approximately 3 cm.It should be understood that the specific dimensions provided herein canvary by 50% or substantially greater, and retain its ability for use asan implant.

To implant such embodiment 600, a vertical perineal incision is made inthe midline dissecting to expose the bulbar urethra and the inferioraspect of the descending rami bilaterally while the patient assumes alithotomy position. A suitable introducer is passed from outside in orinside out through a 3 cm groin incision that is chosen with the fingerin the initial perineal incision to pass through the obturator foramen.A respective end 604 or 606 that is attached to the introducer tip andadvanced within the perineal incision. The introducer is retractedthrough the obturator foramen with the respective other end 604 or 606being grasped at the lateral groin incision site and cut at skin level.The opposite end 604 or 606 is carried over the bulbar urethral complex.A second suitable introducer is passed from outside in or inside outthrough another 3 cm groin incision on the contra-lateral side and theprocess is repeated. The respective ends 604 and 606 of the implant 600are cut at the level of the skin at the groin incisions.

The implant in embodiment 700 depicted in FIG. 7 assumes a generallyrectangular configuration having a width “Q” of 4 cm and a height “R” of3 cm. In accordance with the other embodiments, the implant ispreferably secured into position by making a vertical perineal incisionto the midline dissecting to expose the bulbar urethra and the inferioraspect of the descending rami bilaterally while the patient assumes alithotomy position. A suture secured on a UR-6 needle is then used tobite into the periosteum of the descending rami bilaterally. Althoughnot shown, there will be four sutures altogether on each side for atotal of 8 secured knots to fix the implant 700 into position. The lowerthree sutures on one side are threaded through the implant, which isplaced as high as possible on the bulbar urethral complex. Such lowerthree sutures are loosely held to stabilize the sling and the top apicalsuture is then placed, one on each side at the junction of thedescending rami to the pubic symphysis. The apical sutures are tied downas tight as possible. The three lower sutures are then tied downaccordingly on each side.

In the further embodiment depicted in FIG. 8, the implant 800 assumes agenerally trapezoidal having an upper length “S” of approximately 4 cm,a lower length “T” of approximately 6 cm and a height “U” ofapproximately 3 cm. It should be understood that the specific dimensionsprovided herein can vary by 50% or substantially greater, and retain itsability for use as an implant. Such implant is secured in position viathe initial formation of a vertical perineal incision that is made inthe midline dissecting to expose the bulbar urethra and the descendingrami bilaterally leaving the bulbar spongiosis intact. The implant 800,which will further preferably have access holes 804 formed thereon, isthen placed over the bulbar urethra complex. A fine drill, such as manyof a variety well-known to those skilled in the art, is then advancedthrough each of the holes 804 to secure a preloaded suture. The foursutures that will extend through dedicated ones of the apertures 804 aretied along side of the lateral aspects of the implant 802 to create twoknots on each side. The support portion 802 will then be operative toprovide the necessary degree of suburethral support.

In FIG. 9, there is depicted yet a further embodiment of an implant 900useful in the surgical treatment of male and female urinary incontinenceand falling within the scope of the present invention. Such implant willpreferably have the dimensions of a height “V” of 3 cm and a width of 4cm, as the same pertains to the urethral support portion 902. Eachanchor portion 904, 906 will preferably have a length “X” ofapproximately 20 cm and a width “Y” of 1 cm. Along these lines, itshould be understood that the specific dimensions provided herein canvary by 50% or substantially greater, and retain its ability for use asan implant. Similar to the embodiment depicted in FIG. 3, suchembodiment 900 includes a urethral support portion 902 with two anchorportions 904, 906 extending therefrom in opposed directions. With regardto the best mode by which Applicants would suggest securing such implant900 into position, such surgical procedure would involve the patientassuming a lithotomy position and, in accordance with the otherembodiments discussed above, a vertical perineal incision would be madein the midline dissecting to expose the bulbar urethral and the inferioraspect of the descending rami bilaterally. A suitable introducer wouldthen be passed from inside out or outside in through the upper aspect ofthe obturator foramen. An end portion of a respective one of the anchorportions 904 or 906 is attached through the introducer. The introduceris retracted and the respective other end of the respective other anchorportion 904 or 906 is grasped and a ratchet closure is done, as will beunderstood by those skilled in the art. Support portion 902 is carriedover the bulbar urethral complex. Thereafter, a second suitableintroducer is passed from inside out or outside in on the contra-lateralside and the process repeated with respect to the other respectiveanchor portion 904, 906. The ends of the sling are then secured tosquare-like portions of the urethral support portion 902 at the edge ofthe pubic ramus with a ratchet closure.

FIGS. 10 and 11 illustrate another embodiment of an implant 1000positioned in a female patient as contemplated by the present invention.The implant 1000 is situated such that the support portion 1002 thereofis operatively positioned over the urethra. The implant 1000 as depictedincludes first and second anchor portions 1004, 1006 that are shownextending through the obturator foramen 1008 and wrapped about dedicatedones of the descending rami 1010, 1012 of hip bones 1014,1016,respectively.

FIGS. 12-13 show additional embodiments of the present invention. FIG.12 illustrates one embodiment of an implant 1200 comprising a generallyrectangular shape defining a middle support portion 1202 with anchorportions 1204, 1206 formed integrally therewith and defining first andsecond opposed ends. Preferably, the implant 1200 has a length A′ ofapproximately 45 cm and a width B′ of approximately 1.1 cm tapering downto 0.6 cm at the lateral ends of the implant. It should be understoodthat the specific dimensions provided herein can vary by 50% orsubstantially greater, and retain its ability for use as an implant.

FIG. 13 illustrates another embodiment of the present inventionincluding an implant 1300 defined by a support portion 1302 with anchorportions 1304, 1306 extending in opposing directions therefrom. Thisembodiment includes a support portion with a width C′ of approximately1.65 cm and a length D′ of approximately 2 cm. Anchor portions 1304,1306 may extend from support portion 1302 via a tapered segment (asshown) and will have a length E′ of approximately 20.25 cm and width F′of approximately 1.1 cm. However, one skilled in the art wouldunderstand that the specific dimensions provided herein may be modifiedand still remain within the scope and spirit of the present invention.

Insertion of an implant may be accomplished with various types ofsuitable introducers, including an inside-out transobturator introducer,a helical transobturator introducer or a hook transobturator introduceras commercially available from the assignee of the present application.FIG. 14 shows an embodiment of a pair of inside-out transobturatorintroducers 1400, as contemplated herein. FIG. 15 shows an embodiment ofa pair of helical transobturator introducers 1500, as contemplatedherein. FIG. 16 shows an embodiment of a hook introducer 1600 ascontemplated herein. FIG. 17 shows an embodiment of a suprapubicintroducer 1700 as contemplated herein. FIG. 18 shows an embodiment of atransvaginal (female)/transperineal (male) introducer 1800 ascontemplated herein. One skilled in the art would understand that othersimilar tools and methods are contemplated herein that could accomplishimplantation of the implant as described in the present invention.

The present invention includes methods for placing the implants in afemale patient. In one preferred embodiment using an inside-outtransobturator introducer (FIG. 14) the method begins with a patientfirst assuming a lithotomy position then draining the bladder. Next, amidline longitudinal incision is made in the anterior vagina of thepatient. Thereafter, on one side of the patient, dissection is performedto expose the inferior and superior surfaces of the urethra and lateralpelvic sidewalls.

Dissection should continue by perforating the obturator membrane with ascissors. If the obturator membrane is not reached after penetration ofabout 5 cm, however, the dissection path should be re-evaluated.

Next, the physician selects an implant 1000. In this embodiment, asuture loop (not shown) is attached to each of the anchoring portions1004, 1006 of the implant. The suture loop of one of the anchoringportions 1004 is connected to a slot at the tip of the inside-outtransobturator introducer 1400. The inside-out transobturator introducer1400 is then inserted through the vaginal incision and guided throughthe obturator foramen around the posterior surface of the ischial pubicramus. The introducer 1400 is further guided around the anterior surfaceof the ischial pubic ramus until the tip of the introducer 1400 isexposed in the vaginal dissection.

The suture loop is then removed from the slot of the inside-outtransobturator introducer 1400 and the introducer 1400 is removed fromthe body. The implant 1000 is then pulled through the pathway created bythe introducer 1400 until the end of the implant is exposed at thevaginal dissection. Then the physician performs the same steps for theother side of the patient until the ends of the anchoring portions 1004,1006 of the implant 1000 are now extending through each obturatorforamen of the patient and terminating at the vaginal dissection.

Now the physician secures the implant 1000 in the correct position. Inthis regard, the implant is first aligned mid-urethrally with anappropriate instrument (e.g., a urethral dilator or a curved scissors)placed between the implant 1000 and the urethra to indicate the desiredtension to place on the urethra. While maintaining this tension, thesuture loops of each anchor portion 1004, 1006 of the implant 1000 areremoved and the anchor portions 1004, 1006 are trimmed to the lengthmost suitable for completing the procedure.

To complete the procedure, each end of the anchor portions 1004, 1006may be connected to the support portion 1002 of the implant 1000 with asuture thus securing the implant 1000 around the ischial pubic ramus.Alternatively, each end of the anchor portions 1004, 1006 may be leftloose along the anterior surface of the ischial pubic ramus, thesurrounding tissue serving to secure these anchor portions 1004, 1006 inplace around the ischial pubic ramus. Finally, any excess vaginal mucosain the wound is trimmed and the vaginal incision is closed. If desired,vaginal packing coated with estrogen and/or antibiotic ointment may beplaced in the wound for a period of time, e.g., 12 hours.

In a second embodiment of a method in accordance with the presentinvention, a hook (FIG. 16) or a helical (FIG. 15) transobturatorintroducer is used. In this embodiment, a midline longitudinal incisionis first made in the anterior vagina followed by dissection to exposethe inferior and superior surfaces of the urethra and the lateral pelvicsidewalls. Blunt finger dissection may be used to develop the existingplain inferior to the endopelvic fascia.

On the patient's thigh region, the physician then palpates the medialborder of the obturator foramen in order to locate the base of theadductor longus tendon at the level of the clitoris. At this location,just under the tendon and lateral to the bone, a small incision is madewith a scalpel (e.g., a 15 scalpel). The same small incision is made inthe corresponding location on the other side of the patient. Thephysician then takes either a helical or a hook transobturatorintroducer 1500, 1600 and inserts the introducer through the incision(on one side) and guides the introducer around the posterior surface ofthe ischial pubic ramus until the tip of the helical or hook introducerappears in the vaginal dissection.

An implant 1000 is then selected. In one embodiment, the anchoringportions 1004, 1006 of the implant 1000 will each have a suture loop(not shown) attached thereto. The suture loop is inserted into a slot atthe tip of the introducer 1500 or 1600 and the introducer is then guidedback along its previous path around the posterior surface of the ischialpubic ramus back towards the incision made on the patient's abdomen.

The physician then takes a curved tool, such as a Stewart Crypt Hook(FIG. 19), a suprapubic introducer 1700, or a transvaginal introducer1800 and inserts the curved tool through the vaginal incision and urgesthe curved tool along the anterior surface of the ischial pubic ramustowards the thigh region incision. The user then uses the curved tool tograb the suture loop from the transobturator introducer. The curved toolis then pulled back towards the vaginal incision pulling the anchoringportion of the implant 1000 towards the vaginal incision until theanchoring portion of the implant is exposed in the vaginal incision. Thesuture loop is then removed from the tip of the curved tool and thetransobturator introducer (either hook 1600 or helical 1500) is removedfrom the body. The same steps are then performed for the opposite sideof the patient until both anchoring portions 1004, 1006 of the implant1000 are exposed in vaginal incision.

Now the physician secures the implant 1000 in the correct position. Inthis regard, the implant is first aligned mid-urethrally with anappropriate instrument (e.g., a urethral dilator or a curved scissors)placed between the implant 1000 and the urethra to indicate the desiredtension to place on the urethra. While maintaining this tension, thesuture loops of each anchor portion 1004, 1006 of the implant 1000 areremoved and the anchor portions 1004, 1006 are trimmed to the lengthmost suitable for completing the procedure.

To complete the procedure, each end of the anchor portions 1004, 1006may be connected to the support portion 1002 of the implant 1000 with asuture thus securing the implant 1000 around the ischial pubic ramus.Alternatively, each end of the anchor portions 1004, 1006 may be leftloose along the anterior surface of the ischial pubic ramus, thesurrounding tissue serving to secure these anchor portions 1004, 1006 inplace around the ischial pubic ramus. Finally, any excess vaginal mucosain the wound is trimmed and the vaginal incision is closed. Theabdominal incisions are also closed, preferably with Steri-strips orDermabond. If desired, vaginal packing coated with estrogen and/orantibiotic ointment may be placed in the vaginal wound for a period oftime, e.g., 12 hours.

Additional general procedure aspects for pre- and post-procedureapplications are contemplated herein and further described inApplicant's co-owned and co-pending U.S. patent application Ser. Nos.10/684,861 and 10/947,182, which are herein incorporated by reference intheir entireties.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof the teaching, can generate embodiments and modifications withoutdeparting from the spirit of or exceeding the scope of the claimedinvention. Accordingly, it is to be understood that the drawings anddescriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A method for treating urinary incontinence, comprising the steps of:making a urethral incision exposing urethral tissue in a patient;inserting an elongated implant into said urethral incision; extendingone end of said implant through an obturator foramen of said patient,around an ischial pubic ramus of said patient and back to said urethralincision; extending an opposite end of said implant through the otherobturator foramen of said patient, around the ischial pubic ramus ofsaid other obturator foramen of said patient and back to said urethralincision; positioning a center portion of said implant against saidurethral tissue; and securing said ends of said implant near said centerportion of said implant so as to secure said ends around said ischialpubic ramus.
 2. A method for treating urinary incontinence, comprisingthe steps of: making a urethral incision exposing urethral tissue in apatient; inserting an elongated implant into said urethral incision;extending one end of said implant through an obturator foramen of saidpatient, around an ischial pubic ramus of said patient and back to saidurethral incision; extending an opposite end of said implant through theother obturator foramen of said patient, around the ischial pubic ramusof said other obturator foramen of said patient and back to saidurethral incision; positioning a center portion of said implant againstsaid urethral tissue; and securing said ends of said implant near saidcenter portion of said implant so as to secure said ends around saidischial pubic ramus, wherein said securing said ends of said implantincludes suturing said ends of said implant to said center portion ofsaid implant.
 3. A method as set forth in claim 1, wherein said securingof said ends of said implant includes allowing said ends to be retainedby tissue near an anterior surface of said ischial pubic ramus.
 4. Amethod as set forth in claim 1, wherein said urethral incision is aperineal incision.
 5. A method as set forth in claim 1, wherein saidurethral incision is a vaginal incision.
 6. A method as set forth inclaim 1, wherein the extending of one end of said implant through anobturator foramen of said patient comprises: attaching said one end to atip of an inside-out transobturator tool; and urging said inside-outtransobturator tool through said obturator foramen and back toward saidurethral incision.
 7. A method as set forth in claim 1, furthercomprising: making an incision above said obturator foramen of saidpatient prior to inserting said implant in said urethral incision;inserting a first tool into said incision and urging said first toolthrough said obturator foramen into said urethral incision; and whereinthe extending of one end of said implant through an obturator foramen ofsaid patient comprises: attaching said one end to a tip of said firsttool; withdrawing said tool through said obturator foramen back towardsaid incision; inserting a second tool into said urethral incision totransfer said one end from said first tool to said second tool; andpulling said second tool back to said urethral incision and therebypulling said one end of said implant back into said urethral incision.8. A method as set forth in claim 7, wherein the inserting of said firsttool includes inserting a transobturator helical tool.
 9. A method asset forth in claim 7, wherein the inserting of said first tool includesinserting a transobturator hook tool.
 10. A method as set forth in claim7, wherein the inserting of said second tool includes inserting a curvedtool.
 11. A method as set forth in claim 10, wherein the inserting ofsaid curved tool includes inserting a tool selected from the groupconsisting of a Stewart Crypt Hook, a suprapubic introducer, atransvaginal introducer, and a transperineal introducer.
 12. A method asset forth in claim 1, wherein inserting an elongated implant includesinserting an implant having a central support portion and two opposinganchor portions, said anchor portions being narrower than said centralsupport portion.
 13. A method as set forth in claim 1, wherein insertingan elongated implant includes inserting an implant having a centralsupport portion and at least two opposing anchor portions disposed oneach side of said central support portion.
 14. A method as set forth inclaim 1, wherein inserting an elongated implant includes inserting animplant having a central support portion and at least two opposinganchor portions disposed on one side of said central support portion.15. A method for treating urinary incontinence comprising: exposingurethral tissue in a patient; extending opposite ends of an implantthrough an obturator foramen and wrapping said opposite ends around anischial pubic ramus on either side of said patient; positioning a centerregion of said implant against urethral tissue of said patient; andsecuring said opposite ends of said implant near said center region ofsaid implant.
 16. A method for treating urinary incontinence comprising:exposing urethral tissue in a patient; extending opposite ends of animplant through an obturator foramen and wrapping said opposite endsaround an ischial pubic ramus on either said of said patient;positioning a center region of said implant against urethral tissue ofsaid patient; and securing said opposite ends of said implant near saidcenter region of said implant, wherein the securing of said oppositeends includes suturing said opposite ends to said center region of saidimplant.
 17. A method as set forth in claim 15, wherein the securing ofsaid opposite ends includes allowing native patient tissue to hold saidopposite ends near said center region of said implant.
 18. A method asset forth in claim 15, wherein the exposing of urethral tissue comprisesmaking a perineal incision in said patient.
 19. A method as set forth inclaim 15, wherein the exposing of urethral tissue comprises making avaginal incision in said patient.
 20. A method as set forth in claim 15,wherein the extending and wrapping of said implant involves the use ofan inside-out transobturator tool.
 21. A method as set forth in claim15, wherein the extending and the wrapping of said implant involves theuse of a transobturator helical tool.
 22. A method as set forth in claim15, wherein the extending and the wrapping of said implant involves theuse of a transobturator hook tool.
 23. A method as set forth in claim15, wherein the extending and the wrapping of said implant involves theuse of a suprapubic tool.
 24. A method as set forth in claim 15, whereinthe extending and the wrapping of said implant involves the use of atransvaginal tool.
 25. A method as set forth in claim 15, wherein theextending and the wrapping of said implant involves the use of atransperineal tool.
 26. A method as set forth in claim 15, wherein theextending and the wrapping of said implant includes extending andwrapping an implant having a central support portion and two opposinganchor portions, said anchor portions being narrower than said centralsupport portion.
 27. A method as set forth in claim 15, wherein theextending and the wrapping of said implant includes extending andwrapping an implant having a central support portion and at least twoopposing anchor portions disposed on each side of said central supportportion.
 28. A method as set forth in claim 15, wherein the extendingand the wrapping of said implant includes extending and wrapping animplant having a central support portion and at least two opposinganchor portions disposed on one side of said central support portion.